MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; REVERSE LINERS 36MM (UHMWPE) +3MM

Model Number	1360.50.815
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the devices involved, no pre-existing anomaly was discovered on the items belonging to the same part codes and lot numbers as the components removed.We have not received any additional information from the complaint source, such as removed devices or radiographs; therefore, we cannot investigate further the event.However, according to the surgeon's remarks received, no risk or adverse event occurred.Thus, considering that: no pre-existing anomaly has been discovered on the items belonging to the same part codes and lot numbers as those involved in the event.According to the surgeon's comment, there was no risk or adverse event.We have no evidence to consider the event as product related.Pms data: according to the relevant pms data, the revision rate of the smr reverse liners belonging to the family product codes: 1360.50.Xxx + 1361.50.Xxx + 1365.50.Xxx due to instability is around 0.017%.Based on the root cause analysis performed and according to the relevant pms data, no corrective action is required for this specific case.The manufacturing will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.
Event or Problem Description
Shoulder revision surgery performed on (b)(6) 2025 due to instability.The patient had a reverse shoulder arthroplasty with a 140° reverse body, +3mm liner, and a 36 glenosphere with a +2 adaptor.The patient had stability issues and was taken back to increase liner height and glenosphere lateralization to +6mm liner and +4mm adapter.Therefore, the following components were removed: smr reverse liner + 3 mm (part code: 1360.50.815, lot number: 23at252, sterilization 2400011).Smr glenosphere dia.36mm (part code: 1374.09.111, lot number: 2114595, sterilization 2100307).Smr small-r connector +2 (part code: 1374.15.312, lot number: 2333194, sterilization 2400017).The above-mentioned devices were replaced with the following new ones: smr glenosphere dia.36mm (part code: 1374.09.111, lot number: 2402557, sterilization 2400067).Smr small-r connector lat.+4 (part code: 1374.15.314, lot number: 2412565, sterilization 2400123).Smr reverse liner +6 mm (part code: 1360.50.820, lot number: 23at254, sterilization 2300190).Previous surgery took place on (b)(6) 2024.The patient is a female, date of birth on (b)(6) 1955.The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINERS 36MM (UHMWPE) +3MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 21932842
• Report Number: 3008021110-2025-00039
• Device Sequence Number: 9022376
• Product Code: PHX
• UDI-Device Identifier: 08033390080620
• UDI-Public: 08033390080620
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1360.50.815
• Device Lot Number: 23AT252
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown